32
Participants
Start Date
December 20, 2024
Primary Completion Date
June 30, 2026
Study Completion Date
July 31, 2028
Sacituzumab tirumotecan
Intravesical administration
Rescue medication
Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.
RECRUITING
Johns Hopkins University ( Site 0055), Baltimore
RECRUITING
Hospital Universitario 12 de Octubre ( Site 0042), Madrid
RECRUITING
Hospital Universitario Virgen de la Victoria ( Site 0043), Málaga
RECRUITING
Moffitt Cancer Center ( Site 0057), Tampa
RECRUITING
Hôpital Claude Huriez ( Site 0012), Lille
RECRUITING
Northwestern University ( Site 0051), Chicago
RECRUITING
Michael G Oefelein Clinical Trials ( Site 0053), Bakersfield
RECRUITING
HENRI MONDOR HOSPITAL ( Site 0011), Créteil
RECRUITING
Gustave Roussy ( Site 0013), Villejuif
RECRUITING
Princess Margaret Cancer Centre ( Site 0003), Toronto
RECRUITING
CIUSSS de l'Estrie-CHUS ( Site 0002), Sherbrooke
RECRUITING
Erasmus Medisch Centrum ( Site 0032), Rotterdam
RECRUITING
St Bartholomew s Hospital ( Site 0061), London
Merck Sharp & Dohme LLC
INDUSTRY